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510(k) K193589

TrueTear Intranasal Tear Neurostimulator by Allergan — Product Code QBR

Clearance Details

Decision
SESE (Substantially Equivalent)
Decision Date
August 31, 2020
Date Received
December 23, 2019
Clearance Type
Traditional
Expedited Review
No
Third Party Review
No

Device Classification

Device Name
Intranasal Electrostimulation Device For Dry Eye Symptoms
Device Class
Class II
Regulation Number
886.5310
Review Panel
OP
Submission Type

This device type is intended to temporarily increase tear production using neurostimulation to improve dry eye symptoms. For prescription use only.

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Other clearances for product code QBR

  • DEN170086 — TrueTear Intranasal Tear Neurostimulator (May 17, 2018)